Related Experiment Video

Updated: May 13, 2026

Automatic Separation and Collection of Cancer-Related Substances from Clinical Samples
08:49

Automatic Separation and Collection of Cancer-Related Substances from Clinical Samples

Published on: January 13, 2023

Time Frame Analysis of Medical Device Approval, New Health Technology Assessment, and Reimbursement Decision-Making

Jin-Ho Kim1

  • 1Division of New Health Technology Assessment, National Evidence-Based Healthcare Collaborating Agency, Seoul, Korea. jinho@neca.re.kr.

Journal of Korean Medical Science
|May 12, 2026
PubMed

Insights

The medical device reimbursement process in Korea is lengthy, taking a median of 6.0 years from approval to insurance listing. Streamlining health technology assessment (HTA) and reimbursement is crucial for faster patient access to innovative medical technologies.

Area of Science:

  • Health Economics
  • Medical Device Regulation
  • Health Technology Assessment

Background:

  • The time from medical device approval to health insurance listing, including health technology assessment (HTA), significantly impacts the medical device industry, clinical practice, and patient access to treatments.
  • Understanding the duration of each procedural step is crucial for identifying bottlenecks and improving the overall process.

Purpose of the Study:

  • To analyze the total time frame from medical device approval to health insurance listing via HTA.
  • To examine the duration of individual procedural steps within the reimbursement pathway.

Main Methods:

  • Analysis of publicly available data for 34 medical technologies submitted for HTA and listed for insurance coverage between 2021 and 2023.
  • Examination of timeframes including existing coverage category determination, HTA, and listing processes.

Main Results:

  • The median time from device approval to health insurance listing was 6.0 years for all technologies (n=34).
  • For moderate- to high-risk or novel devices (n=15), the median time was 2.4 years, and 1.5 years for those using the parallel review track (n=8).
  • Median durations for category determination, HTA, and listing were 64.0, 244.5, and 346.0 days respectively for all technologies.

Conclusions:

  • The Korean medical device reimbursement process is lengthy, delaying patient access to new treatments.
  • Streamlining evaluation and reimbursement processes is essential for accelerating patient access to novel medical technologies.
  • Policymakers should focus on enhancing efficiency in the HTA and reimbursement pathway while upholding safety and effectiveness standards.
Abstract

Keywords:
Equipment and SuppliesInsurance, HealthTechnology Assessment, Biomedical

More Related Videos

Isokinetic Robotic Device to Improve Test-Retest and Inter-Rater Reliability for Stretch Reflex Measurements in Stroke Patients with Spasticity08:40

Isokinetic Robotic Device to Improve Test-Retest and Inter-Rater Reliability for Stretch Reflex Measurements in Stroke Patients with Spasticity

Published on: June 12, 2019

Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Issues And Trends In Healthcare Delivery System01:29

Issues And Trends In Healthcare Delivery System

The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...